Linskens Eleni A, De Kesel Pieter, Devreese Katrien M J
Coagulation Laboratory Department of Laboratory Medicine Ghent University Hospital Ghent Belgium.
Department of Diagnostic Sciences Ghent University Ghent Belgium.
Res Pract Thromb Haemost. 2022 Mar 21;6(2):e12633. doi: 10.1002/rth2.12633. eCollection 2022 Feb.
DOAC Filter (DF) is a new device to overcome interference in lupus anticoagulant (LAC) testing by direct oral anticoagulants (DOACs).
We evaluated DOAC removal from plasma and elimination of DOAC interference in LAC testing by DF, and impact of DF on LAC assays in a representative patient cohort, including a comparison with DOAC-Stop (DS).
Normal pooled plasma (NPP) was spiked with increasing concentrations of apixaban, rivaroxaban, edoxaban, and dabigatran. DOAC and LAC was measured on untreated, DF-treated, and DS-treated spiked samples. Coagulation parameters and thrombin generation were measured on patient samples (n = 20) before and after DF. Patients treated with DOAC, vitamin K antagonist, or heparin and nonanticoagulated patient samples (n = 139) were tested for LAC before and after DF.
In spiked NPP, levels were below the lower limit of quantification (LLoQ) after DF/DS treatment for all DOAC concentrations. Following DF, levels were below LLoQ for 53 of 56 DOAC-containing patient samples. Twenty-eight of 33 LAC-positive DOAC-containing samples became negative after filtration, whereas 5 remained LAC-positive (1/5 from a patient with antiphospholipid syndrome [APS]). Four LAC-positive DOAC-containing samples (from patients without APS), became negative after filtration, whereas they remained LAC positive after DS. In the non-DOAC patient groups following DF, LAC changed from positive to negative in 8 (due to a procoagulant effect) and vice versa in 2 cases.
DF reduces DOAC interference in LAC testing. As incomplete DOAC removal may occur, DOAC measurements should be performed after filtration. A procoagulant effect after filtration may lead to erroneous LAC results in non-DOAC-containing samples. Therefore, using DF should be restricted to DOAC-containing samples.
直接口服抗凝剂过滤器（DOAC Filter，DF）是一种用于克服直接口服抗凝剂（DOACs）对狼疮抗凝物（LAC）检测干扰的新设备。
我们评估了DF从血浆中去除DOAC以及消除其对LAC检测干扰的效果，以及DF对一个具有代表性患者队列中LAC检测的影响，包括与DOAC停止器（DOAC-Stop，DS）的比较。
向正常混合血浆（NPP）中加入浓度递增的阿哌沙班、利伐沙班、依度沙班和达比加群。在未处理、经DF处理和经DS处理的加样样本上测量DOAC和LAC。在DF处理前后对患者样本（n = 20）测量凝血参数和凝血酶生成。对接受DOAC、维生素K拮抗剂或肝素治疗的患者以及未抗凝患者样本（n = 139）在DF处理前后进行LAC检测。
在加样的NPP中，对于所有DOAC浓度，DF/DS处理后的水平均低于定量下限（LLoQ）。经DF处理后，56份含DOAC的患者样本中有53份的水平低于LLoQ。33份含DOAC的LAC阳性样本中有28份在过滤后变为阴性，而5份仍为LAC阳性（1/5来自抗磷脂综合征[APS]患者）。4份含DOAC的LAC阳性样本（来自无APS患者）在过滤后变为阴性，而经DS处理后仍为LAC阳性。在非DOAC患者组中，经DF处理后，8例LAC从阳性变为阴性（由于促凝作用），2例反之。
DF可减少DOAC对LAC检测的干扰。由于可能发生DOAC去除不完全的情况，应在过滤后进行DOAC测量。过滤后的促凝作用可能导致不含DOAC样本的LAC结果出现错误。因此，DF的使用应仅限于含DOAC的样本。
